Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000346572
Ethics application status
Approved
Date submitted
15/08/2023
Date registered
26/03/2024
Date last updated
26/03/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of a family-based healthy lifestyle intervention for girls: The Beyond the 80 (BT80) study
Scientific title
The feasibility of a family-based healthy lifestyle intervention for girls: The Beyond the 80 (BT80) study
Secondary ID [1] 310435 0
None
Universal Trial Number (UTN)
Trial acronym
BT80
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 330936 0
Inadequate nutrition 331137 0
Mental health 331138 0
Inadequate sleep quality 331139 0
Inadequate sleep quantity 333353 0
Condition category
Condition code
Public Health 327745 327745 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BT80 will be a 8-week single-arm family-based feasibility study. Approximately, 20 families will be recruited from Western Sydney and will be eligible to participate if at least one female child aged 7–11 years and at least one adult responsible for their care and living in their main household provide consent/assent. Participants must be able to partake in light-intensity physical activity (e.g., walking), have a sufficient understanding of the English language, and willing to commute to Western Sydney University – Campbelltown Campus weekly over the intervention period (tentatively March-May, 2024). No restrictions will be placed on family type (e.g., single parent, blended family). All other family members living in the index child’s main household will be invited to participate but their participation is not required. Each week, for 8 weeks, families will attend Western Sydney University – Campbelltown Campus and they will receive themed education sessions and interactive activities based on building healthy family routines and improving key risk factors affecting young people (i.e., physical activity, muscle-strengthening activity, diet, screen time/sedentary behaviour, sleep). Each week, participants will also participate in rugby league focused physical activity sessions. Sessions will be approximately 80-90 mins each week (split between the education and physical activity sessions). Each week there will be variation in the delivery of the educations sessions where some education and interactive activities will be delivered to parents only or children only, or whole families together. All sessions will be mainly delivered by the research team. Intervention adherence will be monitored through attendance checklists. All outcomes will be assessed twice, at baseline (prior to intervention delivery) and intervention end (i.e., 8-weeks post-baseline), except for the process evaluation outcomes which will only be measured once at intervention end.
Intervention code [1] 326628 0
Lifestyle
Intervention code [2] 326629 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337478 0
Recruitment and retention - measured by enrolling ~20 families and retaining 70% of families (i.e., index parent and index child). Assessed by audit of family tracking spreadsheet.
Timepoint [1] 337478 0
Immediately post-program (8 weeks)
Primary outcome [2] 337702 0
Program satisfaction - measured via questionnaire using a 5-point Likert scale. Target will be 80% for program satisfaction.
Timepoint [2] 337702 0
Immediately post-program (8 weeks)
Secondary outcome [1] 432901 0
Attendance - measured using attendance records. Target will be as at least 70% family attendance (i.e., index parent and index child) over the 8-week intervention period.
Timepoint [1] 432901 0
Immediately post-program (8 weeks)
Secondary outcome [2] 432902 0
Intervention implementation - assessed by fidelity observations using a study-specific checklist.
Timepoint [2] 432902 0
Immediately post-program (8 weeks)
Secondary outcome [3] 432903 0
Participant engagement - measure by direct observation using momentary time sampling.
Timepoint [3] 432903 0
Measured weekly during education and physical activity sessions
Secondary outcome [4] 432904 0
Acceptability - measured using to family interviews exploring acceptability of the intervention and evaluation
Timepoint [4] 432904 0
Immediately post-program (8 weeks)

Eligibility
Key inclusion criteria
• Families must live in Western Sydney. We will invite all family members living in the child’s main household to participate and no restrictions will be set on family type (eg. nuclear family, blended family, single parent).

• Parent(s):
- must be adults aged >18 years with at least one female child aged 7-11 years in their care.
- must have sufficient understanding of the English language to understand recruitment materials and consent forms, verbal description of procedures, and complete questionnaires.
- must be capable of partaking in light-intensity physical activity (e.g., walking)
- must be willing to commute to Western Sydney University – Campbelltown Campus weekly over the intervention period (tentatively March-May 2024)
- must pass a pre-exercise health screening questionnaire and/or provide GP clearance to participate.

• Index child
- must be female aged 7-11 years
- must be capable of partaking in light-intensity physical activity (e.g., walking)
- must pass a pre-exercise health screening questionnaire and/or provide GP clearance to participate.


• Other children
- must be >= 4 years
- must be capable of partaking in light-intensity physical activity (e.g., walking)
- must pass a pre-exercise health screening questionnaire and/or provide GP clearance to participate.
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants who do not pass the pre-exercise health screening questionnaire and do not provide GP clearance will be excluded from participating in physical activity sessions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314448 0
University
Name [1] 314448 0
Western Sydney University Research Partnership Program
Country [1] 314448 0
Australia
Funding source category [2] 314591 0
Commercial sector/Industry
Name [2] 314591 0
Wests Tigers
Country [2] 314591 0
Australia
Primary sponsor type
Other
Name
South West Sydney Primary Health Network
Address
2/1 Bolger St, Campbelltown NSW 2560
Country
Australia
Secondary sponsor category [1] 316390 0
Commercial sector/Industry
Name [1] 316390 0
Wests Leagues Club
Address [1] 316390 0
10 Old Leumeah Road, Lumeah NSW 2560
Country [1] 316390 0
Australia
Other collaborator category [1] 282797 0
Commercial sector/Industry
Name [1] 282797 0
Wests Tigers
Address [1] 282797 0
Concord Oval, Loftus St, Concord NSW 2137
Country [1] 282797 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313621 0
Western Sydney Universities Human Research Ethics Committee
Ethics committee address [1] 313621 0
Locked Bag 1797 Penrith, NSW, 2751
Ethics committee country [1] 313621 0
Australia
Date submitted for ethics approval [1] 313621 0
Approval date [1] 313621 0
14/08/2023
Ethics approval number [1] 313621 0
H15542

Summary
Brief summary
We aim to assess the feasibility and acceptability of the BT80 recruitment strategy, intervention (including intervention fidelity), and accompanying outcome evaluation. In addition, we aim to explore how BT80 could be optimised through a mixed methods process evaluation. BT80 will be a 8-week single-arm feasibility study aiming to recruit 20 families from South-Western Sydney. The findings will provide insight into the feasibility and acceptability of BT80, which will be used to inform a future randomised controlled pilot trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128346 0
Dr Justin Guagliano
Address 128346 0
Western Sydney University Campbelltown Campus Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country 128346 0
Australia
Phone 128346 0
+61 02 4620 3319
Fax 128346 0
Email 128346 0
j.guagliano@westernsydney.edu.au
Contact person for public queries
Name 128347 0
Dr Justin Guagliano
Address 128347 0
Western Sydney University Campbelltown Campus Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country 128347 0
Australia
Phone 128347 0
+61 02 4620 3319
Fax 128347 0
Email 128347 0
j.guagliano@westernsydney.edu.au
Contact person for scientific queries
Name 128348 0
Dr Justin Guagliano
Address 128348 0
Western Sydney University Campbelltown Campus Narellan Rd & Gilchrist Dr, Campbelltown NSW 2560
Country 128348 0
Australia
Phone 128348 0
+61 02 4620 3319
Fax 128348 0
Email 128348 0
j.guagliano@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.